Product image of Mirtazapin Hexal (Mirtazapine) supplied by GNH India

Mirtazapin Hexal

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapin Hexal (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapin Hexal, is a noradrenergic and specific serotonergic antidepressant (NaSSA) presented as an oral tablet for oral use. It is prescribed for the treatment of major depressive disorder in adult patients, helping to improve mood, sleep, and appetite.

GNH India supplies Mirtazapin Hexal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing, regulatory support and consistent product quality across global markets with a focus on timely delivery and compliance with international standards.

Manufacturer / TM Owner

Hexal A/S

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Indications & Clinical Uses

Mirtazapine acts on central neurotransmitter pathways and is approved for several depressive conditions.

  • Major depressive disorder: reduces depressive symptoms and improves overall mood in adults.
  • Bipolar depressive episodes: used as an adjunct to mood stabilizers to treat depressive phases of bipolar disorder.
  • Depression with insomnia: helps alleviate depressive symptoms while improving sleep quality.

How It Works

  • Mirtazapine antagonizes central presynaptic α2‑adrenergic receptors, increasing norepinephrine release, and blocks postsynaptic 5‑HT2 and 5‑HT3 receptors, enhancing serotonergic transmission while reducing serotonergic side‑effects. This combined action restores neurotransmitter balance implicated in depressive states.

Side Effects

Mirtazapine may cause a range of adverse reactions, which are classified by frequency and severity.

Common Side Effects

  • Sedation or drowsiness
  • Increased appetite and weight gain
  • Dry mouth
  • Constipation

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Hyponatremia, especially in elderly patients

Precautions & Warnings

When prescribing Mirtazapin Hexal, clinicians should consider several safety precautions.

  • Monitor weight: patients may experience increased appetite and weight gain.
  • Check blood pressure: orthostatic hypotension can occur, especially at treatment initiation.
  • Assess for suicidal thoughts: heightened risk during early therapy.
  • Use caution in hepatic impairment: dose adjustment may be required.
  • Avoid abrupt discontinuation: tapering reduces withdrawal symptoms.
  • Store at ambient temperature: keep in original container, protect from moisture.

Avoid Interactions

Mirtazapine can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • MAO inhibitors: concurrent use can cause hypertensive crisis; a washout period is required.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): increased risk of serotonin syndrome.
  • CNS depressants (e.g., benzodiazepines, alcohol): additive sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may raise mirtazapine plasma levels.
  • CYP3A4 inducers (e.g., carbamazepine, rifampicin): may reduce mirtazapine concentrations.

Frequently Asked Questions

Mirtazapin Hexal contains mirtazapine, which is prescribed primarily for major depressive disorder in adult patients. It helps alleviate depressive symptoms, improve sleep quality, and may also be used as an adjunct in bipolar depressive episodes.

Mirtazapine blocks presynaptic α2‑adrenergic receptors, increasing norepinephrine release, and antagonizes postsynaptic 5‑HT2 and 5‑HT3 receptors. This dual action enhances overall serotonergic and noradrenergic neurotransmission, contributing to mood improvement.

The appropriate dose of Mirtazapin Hexal is determined individually by the prescribing clinician based on the patient’s condition, response, and tolerability. Dosage adjustments are made according to clinical guidelines and patient needs.

Safety data for mirtazapine in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Clinicians should weigh potential benefits against risks and consider alternative therapies when appropriate.

To order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Mirtazapin Hexal (mirtazapine) belongs to the NaSSA class, offering a distinct receptor profile compared with SSRIs or SNRIs. It often provides stronger sedative and appetite‑stimulating effects, which can be advantageous for patients with insomnia or weight loss, but may be less suitable for those concerned about weight gain.

Store the product at ambient temperature, preferably below 25 °C. Keep it in the original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain product integrity.

Mirtazapin Hexal is taken orally, usually once daily in the evening to take advantage of its sedative effect. Tablets should be swallowed whole with water and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks include agranulocytosis, severe neutropenia, hyponatremia, and rare skin reactions such as Stevens‑Johnson syndrome. Early in treatment, patients should be monitored for worsening depression or emergent suicidal thoughts, especially in younger adults.

Mirtazapin Hexal should be avoided in patients with known hypersensitivity to mirtazapine or any excipients, those currently taking monoamine oxidase inhibitors, and individuals with severe hepatic impairment unless dose adjustments are made under specialist supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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